Denifanstat showed sustained efficacy and favorable tolerability through 52 weeks in a Phase 3 acne extension study, supporting U.S. Phase 3 development.
Written By: Khushi Patel, PharmD
Reviewed By: Pharmacally Editorial Team
Sagimet Biosciences’ denifanstat showed continued improvements across efficacy measures through 52 weeks in an open-label extension of a Phase 3 study in patients with moderate to severe acne vulgaris, supporting continued development of the oral FASN inhibitor in the U.S.
52-Week Results Extend Initial Phase 3 Findings
Patients treated with denifanstat in the Phase 3 open-label extension study (NCT06248008) conducted by Sagimet’s license partner Ascletis BioScience in China showed improvements across all efficacy endpoints evaluated as secondary measures at 52 weeks.
The longer-term findings build on the topline results from the original 12-week randomized, double-blind Phase 3 trial, in which denifanstat met all primary and secondary endpoints. The company reported that denifanstat was generally well tolerated in both the initial study and the open-label extension.
The detailed 52-week results are scheduled for presentation at the European Academy of Dermatology and Venereology Congress (EADV 2026).
Oral FASN Inhibition Targets a Metabolic Pathway in Acne
Denifanstat is a once-daily oral small-molecule inhibitor of fatty acid synthase (FASN), an enzyme involved in fatty-acid synthesis. The drug represents a systemic approach to acne treatment by targeting a metabolic pathway associated with sebaceous gland activity and acne pathophysiology.
Acne affects approximately 50 million people annually in the U.S., with moderate to severe disease accounting for an estimated 10 million cases. Persistent acne can require repeated treatment because inflammatory and non-inflammatory lesions can recur over time.
Ascletis is developing denifanstat as ASC40 for acne in China, while Sagimet is responsible for development in the rest of the world.
AURORA Phase 3 Trial Set for U.S. Initiation
The 52-week findings arrive as Sagimet prepares to advance denifanstat into its U.S. Phase 3 AURORA clinical trial. The company expects the study to begin in the fourth quarter of 2026.
AURORA is a multicenter, randomized, double-blind, placebo-controlled study expected to enroll approximately 800 patients aged 12 years and older, including about 450 adolescents aged 12 to 17 years.
Participants will receive either denifanstat 50 mg or placebo once daily for 12 weeks, with randomization planned at a 2:1 ratio.
The trial will assess three co-primary endpoints at Week 12: treatment success based on a global assessment score, change in inflammatory lesion counts, and change in non-inflammatory lesion counts.
Approximately 530 patients completing the double-blind period will be eligible to enter a 40-week open-label extension to further assess long-term safety.
Longer-Term Data Add to Development Profile
The 52-week extension data provide an important longer-term assessment of denifanstat following the positive 12-week Phase 3 results in China. However, the current announcement does not provide numerical values for the individual efficacy endpoints, so the magnitude of improvement and corresponding statistical analyses cannot yet be independently assessed from the disclosed information.
Sagimet plans to discuss the findings and its U.S. development program during a September 30 virtual event featuring dermatologist Julie Harper, MD, a founding director and former president of the American Acne and Rosacea Society. The company also plans to make a replay available through its investor website for 90 days.
U.S. Phase 3 Development Moves Forward
The 52-week findings reinforce the continued clinical development of denifanstat as Sagimet prepares for AURORA. The upcoming U.S. Phase 3 study will provide controlled efficacy and safety data in both adults and adolescents with moderate to severe acne.
The full 52-week results at EADV 2026 should provide greater detail on the durability of denifanstat’s clinical effects and its longer-term safety profile as the program progresses toward its U.S. Phase 3 milestone.
Reference
Sagimet Biosciences to Host Virtual KOL Event, “Denifanstat Update: 52-Week Data from Phase 3 Open-Label Extension in China and Planned AURORA Phase 3 Clinical Trial in US” on September 30, 2026, Sagimet Bioscience, 28 September 2026
A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris, ClinicalTrials.gov ID NCT06248008
About the Writer
Khushi Patel is a Pharm.D (Linkedin) professional with a strong foundation in clinical pharmacy, patient-centered care, regulatory affairs, and pharmacovigilance, with published work on Brugada syndrome.
Her interests include regulatory affairs, pharmacovigilance, guideline integration, multimodal therapy, pharmacogenomics, and antibiogram utilization, with a focus on evidence-based clinical decision-making and medication safety.
As a Pharmacally healthcare writer, she translates clinical and scientific evidence into clear, accurate, and clinically relevant healthcare content, while continuously developing her expertise in evolving pharmacy practice.